Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
This action is in response to the papers filed on August 06, 2025. Pursuant to amendment filed on August 06, 2025, claims 1, 30, and 32 are amended. Claims 5, 8-13, 15-28 have been canceled.
Therefore, claims 1-4, 6-7, 14, 29-42 are currently under examination.
Priority
The present application was filed on May 26, 2022. Thus, the earlies possible priority for
the instant application is May 26, 2022.
Withdrawn Claim Objections
Upon further consideration, the objection to claim 1 has been withdrawn.
Maintained Claim Rejections - 35 USC § 103
Claims 1-4, 6-7, 14, 29-42 remain rejected under 35 U.S.C.103 as being unpatentable over Warlick et al. (US 2021/0322664 A1), in view of Schultheiss et al. (US 7,507,213 B2,), Owen et al., (US 8,420,381 B2) and Warlick (US 2020/0368377 A1, hereinafter Tissue Regeneration Technologies or ‘TRT’), and further in view of Judson et al. (US 2022/0007638 A1) and Gharib et al. (US 7,255,680 B1).
Regarding claim 1, the therapeutic efficacy of extracorporeal shock wave therapy in biological systems is well recognized in the prior art. Warlick teaches a method of treating a harvested organ and tissue, the connective tissue blood, for preservation for implantation into a patient comprising the steps of harvesting an organ or tissue from a donor, placing the harvested biological material into a container, filling the container with a fluid, sealing the container once filled, and directing one or more sound wave treatments into the container to destroy bacteria or molds or fungi or virus and to stimulate the organ or tissue (Abstract; [0006]; Fig. 5A; Claim 1-6). Furthermore, Warlick teaches research was conducted on lungs, directly or even indirectly, which is applied to the methods discussed methods pertaining to blood expounded upon in the referenced prior art ([0008]). Warlick clearly teaches that shock waves are able to destroy the bacteria biofilms, breaking down the resistance of the bacteria, and direct treatment of the connective tissue using sound waves eradicates bacteriological organisms, fungi and exposes viruses to be unmasked allowing the bodies defense systems to destroy these viruses ([0005]; [0014]). Warlick teaches procedural specifics of shock wave application to biological material throughout, including the application of asymmetric wave profiles to generate pressure pulses, and the outputting of 100 to 3000 acoustic shock waves ([0057]; [0061-0062]).
Moreover, the disclosure of Warlick teaches unambiguous motivation to use containers for acoustic shock wave organ treatments:
"The development of acoustic sound waves or pressure pulses over the last decade in the treatment of tissue and organs. They have led the medical community in a variety of breakthrough medical treatments for a variety of conditions. Recently, they discovered that pressure pulses or acoustic sound waves could, contrary to the common belief, be applied directly to the thin delicate tissue membranes of the lungs. Heretofore, those skilled in the art felt that directing such energy to the lungs would risk tearing or rupturing the lung. Shields and other devices were developed to prevent this from occurring. In particular, in treating the heart with sound waves, the inventors went to great trouble to avoid an emission path that would impinge the lung sacs. Recently, one of these same inventors discovered a unique way to overcome these concerns and treat the diseases of the lungs directly using acoustic waves and pressure pulses without risk of damage to the lung tissue. These novel methods are also described herein. In conducting this research on lungs, directly or even indirectly, the inventors also contemplated treating the red blood cells directly, preferably externally of the patient using acoustic shock waves or pressure pulses to help purify an infected patient's blood supply ([0006-0008]).
Warlick teaches that the acoustic shock waves or pressure pulses activate a cellular response and the emitted acoustic shock waves or pressure pulses stimulating the stimulated blood cells fragment the virus in the blood (Abstract). The high velocity cavitation microjets generated during the collapse of the cavitation bubbles play an important role in permanently breaching the membranes of bacteria and viruses and thus destroying them ([0012]), and a direct treatment using sound waves eradicates bacteriological organisms, fungi and virus ([0005]). This response or stimulation causes an increase of nitric oxide and a release of a variety of growth factors such as VEGF and a release of anti-microbial peptides ([0086]).
Warlick teaches the emitted shock waves or pressure pulses stimulate the blood cells and fragment the virus in the absence of cell damaging cavitation due to an elasticity in the blood cells ([0020]). Moreover, Warlick teaches these shock wave energy transmissions are effective in stimulating a cellular response and can be accomplished without creating the cavitation bubbles in the blood (abstract; [0060]).
Hence, Warlick teaches the application of the container as one avenue or means of shielding the organ and mitigating potential negative effects of the direct application of shock wave treatments. While Warlick teaches the application of shock waves can be done in different ways and a gradual increase in the number of impulse numbers directed at lung tissue exhibited advantages, the methods taught are primarily directed to in vivo and in vitro applications of blood ([0016-0019]). However, the ordinary artisan would have recognized that parallel applications of acoustic shock waves were routinely used for organ treatment, by additional teachings in the prior art specifically directed to organs.
Schultheiss further teaches a method of treating a harvested organ for preservation for implantation or transplantation into a patient using acoustic shock wave treatments on organs directly wherein the organ is removed from the patient's body as is the case in transplants or while the organ is exposed due to a surgical procedure permitting a direct transmission of the acoustic waves without interfering tissue or skeletal bone mass (claim 14; column 2, lines 37-44). Additionally, Schultheiss teaches the suitability of these methods for exposing the organ to shock waves, either prior to or after being transplanted, for example a heart, liver, kidney, portions of the brain or any other organ or portions thereof of a human or animal which may be transplanted into a patient (column 10, lines 6-11; claim 14).
In applying such methods, Schultheiss teaches the applicability of an acoustic pressure pulse shock wave generator or source able to emit a pressure pulse or acoustic shock waves from a shock wave head, the pressure pulse being an acoustic pulse which includes several cycles of positive and negative pressure, wherein the pressure pulses have an energy density in the range of about 0 .00001 mJ/mm2 to about 1.0 mJ/mm2 (claim 1). Schultheiss teaches the application of these methods have the physiological result of increasing the stimulation of growth factors, activation of healing acceleration (column 10, lines 6-11), improved tissue regeneration, germicidal cleanliness (column 2, lines 45-48), and cleaning of diseased or infected areas (column 8, lines 30-32).
The combined teachings of Warlick and Schultheiss are not directed at the sealing the container, removing residual air or other limitations having to do with placing a biological material into a container for downstream applications, such as flushing the organ.
However, the preservation of the organ by storage within a container at a hypothermic temperature, sealing an air tight container, or other technical steps such as flushing the organ prior to transplant are routine and deemed merely a matter of judicious selection and routine optimization that is well within the purview of skilled artisan, in view of Owen. Owen teaches a method to sustain and restore viability of organs and preserve organs for storage and transport by perfusing the organ at hypothermic temperatures, preferably after hypothermic organ flushing and storage at temperatures of 4 °C (Abstract; Fig. 16). Additionally, Owen teaches the utility of a container holding a fluid solution for preservation purposes (column 8-column 9). Owen teaches an organ or tissue treated ex vivo by mechanical, physical, chemical manipulation and modification to treat disease and treat damage to enhance the properties of the organ or tissue. Furthermore, it is well known in the art that hypothermic conditions of about 4°C are appropriate for organ or tissue storage for transplantation. Additionally, Owen teaches a vacuum source used to apply a vacuum removal of gasses with vacuum venting (column 19, lines 29-38 and column 22 lines 16-21).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to combine the teachings of donor tissue harvesting and placement in a container for exposure to acoustic sound wave treatments to destroy bacteria, fungi, or viruses and physiological stimulation, as taught by Warlick, with the teachings of shock wave treatments of organs and physiological advantages for transplant, as taught by Schultheiss, with the routine preservation techniques, such as preservation fluid flushing and hypothermic conditions for treating a harvested organ or tissue for preservation for implantation into a patient, as taught by Owen.
In short, Warlick discloses the application of asymmetric acoustic shock waves to biological tissues and fluids within containers for microbial deactivation and stimulation of healing processes. Schultheiss complements this by teaching applying shock waves directly to harvested organs for cleaning, disinfection, and regeneration, particularly in transplantation contexts. Owen further teaches the method of enclosing an organ in a flexible container that is sealed, air is removed, and stored at hypothermic temperatures, and also teaches administering preservation fluids or medications. All of the references are from analogous fields and directed to organ and biological fluid treatment systems. Furthermore, the ordinary artisan seeking to apply the taught acoustic shock waves to an organ transport or storage container filled with a fluid for preservation and chemical therapeutic for delivery would have recognized applicable teachings specifically involving fluid containment, pressure control, and storage or preservation environments.
As previously communicated in the previous phase of prosecution, Tissue Regeneration Technologies or TRT explicitly teaches combining drug administration with shock wave treatments to enhance uptake via increased membrane permeability ([0012-0013]). Tissue Regeneration Technologies teaches a method of treating a patient having inflammation or an infection from bacteria or molds or fungi or virus by destroying bacteria or molds or fungi or virus with the step of directing one or more sound wave treatments into the patient to destroy bacteria or molds or fungi or virus. The sound wave treatments cause a disruption of cellular membranes and a cellular communication causing the patient's cells to identify and attack the bacteria, mold fungi or virus and further causes recruiting or stimulating an increase in anti-microbial peptides. The method is taught to further comprise the step of administering medications to the patient including, but not limited to anti-viral medications, antibiotics, anti-fungal medications or anti-mold medications, wherein the sound wave treatment extends the useful life of the medications (Abstract). Additionally, TRT teaches the sound wave treatments increase the permeability of the patient's cell membranes allowing an increase in releasing anti-microbial peptides and inflow of the medications into the cells while increasing the blood supply toward the infection ([0012]).
Moreover, to establish clearly for the record, regarding the configuration of the container and sealing to increase the perfusion of medicaments into the organ, it would have been an obvious design implementation as the ordinary artisan would have recognized increasing positive pressure within the contain for increasing fluid movement into the organ was known in the art, see Judson and Gharib. The ordinary artisan would have recognized proper sealing of the container to obtain the taught pressure as an obvious optimization, a fundamental requirement in maintain the pressure of a system (the physical definition of pressure is force per unit area), as well as configuration of the sealing contain to be flexible.
The considerations pertaining to the limitation of positive pressure of a container to increase fluid exchange within a living tissue have already been known in the prior art, and do not require the application of acoustic shock waves, further in view of Judson. In order to obtain pressure differentials within and outside of a given system, the separation or sealing off of the environments would clearly be obvious to the ordinary artisan. For example, Judson confirms the practice of treating organs in sealed containers during storage while delivering antimicrobial agents was recognized in the prior art (Abstract). Judson discusses the development of the field of organ transport containers from simple sealed bags to more advanced transport containers like ‘picnic cooler’ transport and improved perfusion transport systems, as well as specific structural and functional limitations of the container, such as sealing, positive pressure gradients to promote fluid exchange of the organ and its environment, and other obvious limitations, such as flexibility of the bag ([0009-0011]; [0019]; [0085]; [0101]; [0104-0106]; [0129]; [0132]; [0151-0151]). Additionally, the teachings of Judson make evident that there are multiple methods to achieve a positive pressure with the aim of perfusing tissues or increase fluid exchange with an organ and its environments, such as utilizing gasses concentration and fluid dynamics ([0105]).
Gharib further provides strong teachings for fundamental physical chemistry applications for parallel systems for positive pressure creation for fluid movement and tissue or organ perfusion, monitoring and regulating flow through pressure sensing and downstream resistance calculations, and proper sealing to increase efficiency of the positive pressure infusion system (Abstract; claims 1-40). The combination of these references renders all structural and functional limitations obvious, as each step represents a known action in organ preservation or treatment, arranged in a predictable order to achieve a known effect: preservation and decontamination of a harvested organ using known physical and chemical means, sound waves and pharmacological drugs. The initial step of removing infected tissue prior to treatment is standard in transplant surgery and would be readily implemented by one skilled in the art.
This combination of prior art teachings would have enabled the ordinary artisan to obtain a method of treating an organ with acoustic shock waves in a container appropriate for preservation of viability for transplantation, with a reasonable expectation of success. It is prime facie obvious to combine prior art elements according to known methods to yield predictable results, particularly in light of the multiple advantages of acoustic shock therapy as a treatment of organ in a container fit for such treatment, as taught by Warlick, Schultheiss, and TRT, along with the advantages of Owens teachings for prolonging the time that an organ may be available for ex vivo treatment utilizing related methods (column 26, lines 31-32), and further in view of Judson’s and Gharib’s teachings on structural container design for analogous functional effects targeted at driving fluid movement for organ perfusion and preservation.
Regarding claims 30, 32, 37, these claims specify plural shock wave treatments applied before or after medication administration, or before and during hypothermic storage. Warlick and TRT teachings make clear that the ordinary artisan would have expected that timing of shock wave applications would have significantly influenced cellular permeability and therapeutic efficacy. TRT expressly discloses the dual combination of shock wave and drug delivery, where the sound wave treatment is applied “either prior to, during or after administering medications or any combination thereof” (Claims 3-8, 18, 22, 29-24[0062], and [0084]). As already discussed, the ordinary artisan would have recognized additional prior art teachings, such as Judson’s teaching that therapeutic treatments during storage in a sealed container are routine in organ preservation systems. Claim 37’s recitation of a first and second shock wave treatment is a predictable optimization, and the configuration and timing of multiple treatments would have been an obvious variation based on known pharmacokinetic considerations.
Furthermore, Warlick teaches repeated treatments may be administered, where the energy density values of the shock waves range as low as 0.000001 mJ/mm2 and having a high-end energy density of below 1.0 mJ/mm2, preferably 0.40 mJ/mm2 or less, more preferably 0.20 mJ/mm2 or less ([0086]). The peak pressure amplitude of the positive part of the cycle should be in the range of nano-second up to some milliseconds and its duration is below 1-3 microseconds. Hence the sequential administration of acoustic shock wave pulses of analogous ranges and durations was well known in the art. Furthermore, “When a patent ‘simply arranges old elements with each performing the same function it had been known to perform’ and yields no more than one would expect from such an arrangement, the combination is obvious.” See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007) at 1395-1396, quoting Sakraida v. AG Pro, Inc., 425 U.S. 273 (1976) and In re Fout, 675 F.2d 297, 301 (CCPA 1982) (“Express suggestion to substitute one equivalent for another need not be present to render such substitution obvious”).
A person of ordinary skill in the art would have been motivated to select appropriate structural and functional parameters, based on known physical and chemical system dynamics, as taught in the prior art, to arrive at the claimed subject matter through routine experimentation. As per MPEP § 716.02, [a]ny differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Regarding claim 2, the combined teaching of Warlick, Schultheiss, Owen, TRT, Judson, and Gharib render claim 1 obvious. Additionally, Warlick teaches a special feature of the device being a container through which a shock wave application to the tissue can take place ([0019]). Moreover, Warlick teaches an exemplary pressure pulse/shock wave generator device contacting a bag or container, and advantages of such an unfocused beam are the acoustic wave could be directed to pass through a container without causing any cell rupturing ([0054]).
Furthermore, the use of shockwave-permeable materials is implicit and necessary in Warlick’s treatment method, which places the shock wave source in direct contact with the exterior of the container. The ordinary artisan would have realized the container must be acoustically transmissive, in order to target the organs tissue, and a functional prerequisite for shock wave transmission would have been obvious to one of ordinary skill in the art at the time of the invention, in light the explicit teachings such as Warlick, Schultheiss and TRT.
Regarding claim 3, the combined teaching of Warlick, Schultheiss, Owen, TRT, Judson, and Gharib render claims 1 and 2 obvious. Additionally, Warlick teaches a bag along with exemplary shock wave device emitting shock waves via a flexible hose, flexible membrane ([0054] and [0078]). While Warlick does not expressly state that the bag is flexible, it would have been obvious to one of ordinary skill in the art to use the known technique of flexibility for exemplary shock wave delivery to improve the similar membrane of the bag in the same way as the flexible membrane or hose, by utilizing a similar flexible material. Likewise, Judson discusses how flexibility allows for the container to move in response to mechanical shock, thereby reducing tissue damage ([0098]; [0107]; [0116]; [0129]). Additionally, Gharib teaches how bag collapsibility directly relates to positive-pressure flow or infusion (column 2, para. 2; claim 13). Thus, the use of a flexible bag for organ containment and treatment would have been a predictable design choice based on known materials and methods, particularly where flexibility facilitates pressure control, sealing, and acoustic energy delivery.
Regarding claim 4, the combined teaching of Warlick, Schultheiss, Owen, TRT, Judson, and Gharib render claims 1 obvious. Additionally, Warlick teaches directing sound wave treatments by placing an acoustic shock wave or pressure pulse emitting applicator against an external surface of the container ([0078]). As shown in Figure 5A, Warlick applies pressure pulses directly to the outer surface of a flexible container holding biological material. The use of a handheld or mounted applicator emitting acoustic pressure pulses into a container is fundamental to the method taught by Warlick, and this direct contact-mode delivery of pressure pulses was standard in the field of shock wave therapy ([0028]; [0058-0059]).
Thus, it would have been obvious to one of ordinary skill in the art to implement a pressure pulse-emitting applicator in contact with the container, since Warlick provides both the explicit structure and operational rationale for doing so. Such contact would have been reasonably expected to ensure effective energy transmission and is a standard configuration in shock wave applications, including extracorporeal shock wave applications.
Regarding claim 7, the combined teaching of Warlick, Schultheiss, Owen, TRT, Judson, and Gharib render claims 1 obvious. Additionally, Warlick teaches the improvement of blood supply using acoustic shock waves to help purify an infected patient's blood supply ([0008]). Warlick also teaches the envelope of viruses are less elastic than the membrane of cells, and teaches shock waves have the property of exerting forces on the virus via mechanotransduction at very high speed, but the envelope of the virus does not have sufficient elasticity and breaks. The fragility of the fragmented envelope to is used to eradicate the virus ([0011]). Warlick teaches the use of acoustic pressure pulses or shock waves to treat blood in containment ex vivo by employing multiple and sequential applicators to damage pathogens using significant cavitation. The high velocity cavitation microjets generated during the collapse of the cavitation bubbles play an important role in permanently breaching the membranes of bacteria and viruses and thus destroying them ([0012]). Finally, Warlick teaches the acoustic shock waves or pressure pulses activate a cellular response within the blood. This response or stimulation causes an increase of nitric oxide and a release of a variety of growth factors such as VEGF and a release of antimicrobial peptides ([0086]).
The claimed immune or microbial defense stimulation is a well-known physiological effect of mechanical or drug-based tissue stimulation, and thus would have been reasonably expected by one of ordinary skill in the art seeking to promote tissue regeneration or pathogen resistance.
Regarding claims 14, 29, 31, and 33, the combined teaching of Warlick, Schultheiss, Owen, TRT, Judson, and Gharib render claims 1, 2, 30 and 32 obvious. Warlick teaches the steps of activating an acoustic shock wave or pressure pulse generator to emit acoustic shock waves or pressure pulses, along with the energy pressure pulse/shock waves being unfocused shock waves or pressure pulses (Abstract; [0058]; [0063-0065]; and 0085). Moreover, Warlick teaches the acoustic shockwave or acoustic wave generator or source can be a spherical, ballistic, radial, piezoelectric, electrohydraulic, electromagnetic or other similar device ([0022] and [0077-0078]). Schultheiss teach wherein the pressure pulses of the shock waves treatments are unfocused pressure pulses/shock waves (column 6, first and last para.). Thus, it would have been obvious to the ordinary artisan to use unfocused pulses in this context to achieve broader coverage and reduce focal intensity, a predictable and routine design choice in acoustic treatment systems.
Regarding claims 6, 34-36, 38, 40, and 42, the combined teaching of Warlick, Schultheiss, Owen, TRT, Judson, and Gharib render claims 1, 30, 32, 37, 39, and 41 obvious. These claims collectively recite that the container is secondarily sealed to apply tension and create a positive pressure condition within the container or bag. Warlick teaches the application of pressure pulses to generate an acoustic pulse which includes several cycles of positive and negative pressure ([0028] and [0059]). Owen teaches the used of seals for the organ container (column 9, lines 63-66). Additionally, as already explained, basic, routine, and conventional steps such as sealing, container flexibility and suitability for pressure pulse applications, to generate a positive bag or bladder internal pressure and fluid dynamics were taught by Judson and Gharib.
It would have been obvious to one of ordinary skill in the art to secondarily seal, further compartmentalize, or tension the container to create positive pressure and fluid gradient within the preservation bag or container, as taught by Gharib and supported by Owens and Judson. The known benefit of increased fluid-tissue contact, enhanced drug delivery, and mechanical stabilization would motivate such a modification. Applying tension via secondary sealing is simply a predictable mechanical adaptation to increase perfusion efficiency in a sealed biological treatment environment, in view of the prior art.
Regarding claims 39 and 41, the combined teaching of Warlick, Schultheiss, Owen, TRT, Judson, and Gharib render claims 37 obvious. Warlick teaches the direct treatment of blood using sound waves eradicates bacteriological organisms, fungi and exposes virus to be unmasked allowing the bodies defense systems to destroy these viruses ([0005]). Schultheiss additionally teaches subjecting the organ to pressure pulses or acoustic shock waves includes killing bacteria by destroying bacterial cell membranes or stimulating a biological defense mechanism within said organ by exposure to the acoustic shock waves (claim 12). TRT explicitly teaches the coadministration of anti-viral medications, antibiotics, anti-fungal medications or anti-mold medications, wherein the sound wave treatment extends the useful life of the medications (Abstract; claims 3, 18, and 29). The additionally relied upon teachings further teach fluid preservation fluids containing antimicrobial agents (Owen and Judson).
Response to Applicants’ arguments as they apply to the rejection of claims 1-4, 6-7, 14, 29-42 under 35 USC § 103
Applicant's arguments filed August 6, 2025, have been fully considered but they are
not persuasive.
At pages 10-14 of the remarks filed on August 6, 2025, Applicants essentially argue the
following:
Applicant argues that Warlick cannot be combined with Schultheiss because Warlick teaches treatment of blood while Schultheiss teaches direct organ treatment.
This argument is not persuasive because the rejection does not rely on Warlick as teaching the treatment of blood per se, but rather as teaching the application of acoustic shock waves through a container and fluid medium to biological material. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
The fact that Schultheiss shows direct transmission without fluid does not teach away from using fluid. To the contrary, in this case, Warlick explicitly teaches shock-wave propagation through fluid-filled containers and stimulation of cellular material. Schultheiss establishes that shock wave therapy is routinely applied to harvested organs, supporting the obviousness of the applicability of method to organs. The combination therefore reflects the general and well recognized principle of the shock wave therapy or modality across biological tissues. Therefore, the ordinary artisan would have readily recognized that the deliver approach of Warlick and the organ-targeting application of Schultheiss are complementary, not conflicting.
Applicant argues that the remaining references cannot cure the alleged deficiencies in the primary combination
This argument is not persuasive because the obviousness rejection relies on the combined teachings of all the cited references, not solely on Warlick and Schultheiss. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Here, TRT teaches sequencing of shock-wave treatments relative to drug administration. Judson teaches sealed organ-storage containers and management of pressure within those containers. Gharib teaches flexible containers capable of maintaining positive pressure.
Applicant argues that adding “flushing blood from the harvested organ” distinguishes the claims. Applicant argues that claim amendments, flushing blood, and fluid-based acoustic transmission render the claims non-obvious.
This argument is not persuasive because cited prior art teachings, such as Owens demonstrate flushing blood from a harvested organ is a routine, established, and conventional step in organ procurement and preservation techniques. In view of the referenced prior art, the ordinary artisan would have reasonably expected flushing to occur before placing an organ into the preservation container and subjecting it to the additional treatments, including shock waves. Thus, the person of ordinary skill in the art would have recognized, regarding organ preservation and infection control, flushing as a standard preservation protocol is a routine pre-treatment step, established in clinical practice. In this case, the ordinary artisan who sought apply the taught methods would have recognized the recited steps, such as flushing, placing the organ in a sealed and pressurized container (free of air) were predictable and established practices.
Conclusion
Claims 1-4, 6-7, 14, 29-42 are rejected. No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/J.D.L./Examiner, Art Unit 1633
/CHRISTOPHER M BABIC/Supervisory Patent Examiner, Art Unit 1633